The Effect of Weight Bearing on Patient Outcomes Following 1st MTP Joint Fusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNova Scotia Health Authority
About this trial
randomized-controlled trial looking specifically at the effect of weight bearing on the outcomes of first MTP joint fusions
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or great
Medically fit for surgery
Patients diagnosed with condition for which a 1st MTP joint fusion is a surgical management option based on clinical examination and radiographs
Failed non-operative management (orthotics, bracing, Tylenol, NSAIDs, shoe-wear modification)
Disqualifiers
Age <18 years old
Surgical booking is for more than just 1st MTP fusion
Unable to comply with follow up schedule and requirements
Unable to provide informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
weightbearing
Other interventionimmediate weightbearing
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: WeightbearingActive comparator 1 intervention
Group B: Non weightbearingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Foot and Ankle Ability Measure (FAAM)
Activities of Daily Living (ADL) Scored out of 100\\higher score indicates more function
Time frame
pre op2
Foot and Ankle Ability Measure (FAAM)
Activities of Daily Living (ADL) Scored out of 100\\higher score indicates more function
Time frame
6 months3
Visual analogue scale(VAS)
patient reported outcomes of pain. Scale of 1-10. Higher score indicating more pain
Time frame
pre op4
Visual analogue scale(VAS)
patient reported outcomes of pain Scale of 1-10. Higher score indicating more pain
Time frame
12 weeksSecondary outcomes
1
Radiographic healing
Union is defined as new bone formation across the cortex of the fusion site
Time frame
6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov